NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Metastatic castration-resistant prostate cancer that has progressed following taxane-based therapy
Date of first enrollment	01/3/2011
Target sample size	1099
Countries of recruitment
Study type	INTERVENTIONAL
Intervention(s)	Intervention name : Orteronel (TAK-700) Dosage And administration of the intervention : Oral Control intervention name : Placebo Dosage And administration of the control intervention : Oral

Outcome(s)

Primary Outcome	Overall survival (OS)
Secondary Outcome	Radiographic progression-free survival (rPFS), 50% prostate specific antigen (PSA) response, Pain response

Key inclusion & exclusion criteria

Age minimum	18
Age maximum
Gender	Male
Include criteria	- Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma - Radiograph-documented metastatic disease - Progressive disease - Prior surgical castration or concurrent use of an agent for medical castration - Prior docetaxel therapy - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Exclude criteria	- Documented central nervous system metastases - Current spinal cord compression, bilateral hydronephrosis or current bladder neck outlet obstruction - Uncontrolled cardiovascular condition as specified in study protocol - Uncontrolled nausea, vomiting or diarrhea